August 10, 2021 – INDIANAPOLIS, INDIANA – POINT Biopharma Global Inc. (NASDAQ: PNT), a company accelerating the discovery, development, and global access to life changing radiopharmaceuticals, today announced the completion of enrollment and initial dosing of the 25-patient safety and dosimetry lead-in of the Company’s Phase 3 SPLASH study evaluating PNT2002 for the treatment of metastatic castration-resistant prostate cancer (mCRPC).
“Patient enrollment and initial dosing was completed significantly ahead of schedule,” said Dr. Joe McCann, Chief Executive Officer of POINT Biopharma. “I am incredibly proud of our team for this achievement, especially considering it occurred during an unprecedented global pandemic. I believe the speed of enrollment further highlights the caliber of POINT’s team, as well as the unmet need of patients and physicians for additional treatments for advanced prostate cancer.”
The open-label safety and dosimetry lead-in enrolled patients with PSMA-expressing mCRPC who have progressed on ARAT therapy and are ineligible or averse to chemotherapy. Data generated from the initial safety lead-in phase of the study will be analyzed before proceeding to the randomization phase, with site initiation in the United Kingdom and several European Union countries beginning shortly thereafter. Patient treatment and follow-up remain ongoing, and the Company expects to report data from this phase of the study at a future scientific conference.
“On behalf of the entire POINT Biopharma team, I would like to extend our gratitude to the patients, their families and treating physicians for their enthusiasm and support for our Phase 3 SPLASH study,” said Dr. Neil Fleshner, Chief Medical Officer of POINT Biopharma. “Completing the enrollment of the safety and dosimetry lead-in is an important step on our journey to offer a new treatment option to patients battling mCRPC, a highly aggressive form of cancer with few therapeutic options. We look forward to starting the randomization part of the trial phase globally.”
The Phase 3 SPLASH study (NCT04647526) is a multi-center, randomized, open label assessment of PNT2002 in patients with PSMA-expressing mCRPC who have progressed on ARAT therapy and refuse or not eligible for chemotherapy. The next phase of the study is expected to enroll approximately 400 patients across North America, Europe and the UK. Patients will be randomized 2:1 with patients in arm A receiving PNT2002 and patients in arm B receiving either Abiraterone or Enzalutamide. Patients in arm B who experience centrally assessed radiographic progression and meet protocol eligibility will have the option to crossover and receive PNT2002. Patients will be subject to follow-up for up to 5 years from first PNT2002 dose. The primary endpoint of the study is radiographic progression-free survival (rPFS). Key secondary endpoints include overall response rate (ORR), overall survival (OS), and pharmacokinetics (PK).
Additional information on the Phase 3 SPLASH study can be found at https://www.splashtrial.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in this press release include, but are not limited to, statements regarding the benefits of the recently completed business combination, as well as statements about the potential attributes and benefits of New POINT’s product candidates and the format and timing of New POINT’s product development activities and clinical trials. We cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward-looking statements are subject to a number of significant risks and uncertainties that could cause actual results to differ materially from expected results, including, among others, the outcome of any legal proceedings that may be instituted against New POINT following the closing of the business combination, the risk that the business combination disrupts current plans and operations, the ability to recognize the anticipated benefits of the business combination, which may be affected by, among other things, competition, the ability of New POINT to grow and manage growth profitably and retain its key employees, the impact of COVID-19 on New POINT’s business, the ability to maintain the listing of New POINT’s common stock on the NASDAQ, changes in applicable laws or regulations, the possibility that New POINT may be adversely affected by other economic, business, and/or competitive factors, and other risks and uncertainties, including those described in RACA’s definitive proxy statement filed with the SEC on June 9, 2021. Most of these factors are outside of New POINT’s control and are difficult to predict. Furthermore, if the forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. The forward-looking statements in this press release represent our views as of the date of this press release. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we have no current intention of doing so except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release.